Cleared Traditional

K924459 - DIGISCAN 2

K924459 is an FDA 510(k) clearance for DIGISCAN 2, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code IXK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K924459 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 1992
Decision
106d
Days
Class 2
Risk

K924459 is an FDA 510(k) clearance for the DIGISCAN 2. Classified as System, Imaging, X-ray, Electrostatic (product code IXK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1630 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K924459

510(k) Number K924459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1992
Decision Date December 17, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXK Device Classification - Class 2, Special Controls

Product Code IXK System, Imaging, X-ray, Electrostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IXK System, Imaging, X-ray, Electrostatic

All 7
Devices cleared under the same product code (IXK) and FDA review panel - the closest regulatory comparables to K924459.
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K924012 · Fujifilm Medical System U.S.A., Inc. · Oct 1992